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European Commission to determine if Spikevax will receive emergency approval for children aged 12 to 17
The European Medicines Agency’s (EMA) human medicines committee, known as the Committee for Medicinal Products for Human Use (CHMP), has recommended that the EU’s European Commission broadens the emergency use of Moderna’s mRNA Covid-19 vaccine, known as Spikevax, to also include adolescents 12-17 years of age.
It is currently authorized for use in individuals aged 18 and older.
To clarify, the protocol for administering Spikevax to this younger age group will be the same as the others—it will be provided as two doses, four weeks apart.
“The CHMP recommendation of the authorization of our Covid-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group,” notes Stéphane Bancel, CEO of Moderna. “As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall.”
In June, in the US, Moderna submitted an emergency use authorization (EUA) to FDA for this same age group.